1. Field of the Invention
The present invention is directed to a suturing device and method, and more particularly to a suturing device and method for creating a secure suture knot by blooming of the free suture end.
2. Brief Description of the Related Art
Suturing of body tissue is a time consuming and delicate task that generally requires skilled knot-tying by surgeons or physicians. Typically, during surgery it is necessary for a surgeon to suture tissue together to close an incision or wound. To secure the suture, a knot is tied. As related to medical procedures, knot tying is a complicated skill that is difficult to master, and many surgeons and physicians are not sufficiently trained to complete this task properly.
Several factors make surgical knot-tying difficult. First, a suture will frequently require multiple accumulated (e.g., three to five) knots in order to maintain the suture at a proper tightness, and the strength of the knot depends in large part on the surgeon's knot-tying technique. Second, all conventionally tied knots suffer varying degrees of knot-slippage and suture breakage which may weaken the suture construct. Moreover, since conventional knot-tying is done by hand, surgical suturing can be challenging when an incision is located nearby or in deep tissue areas of the body. Without a tightly secured suture knot, there is a greater risk of tissue dehiscense (e.g., splitting open) which can lead to bleeding, infection, and the possibility for revision surgery.
Due to the difficulty and high degree of expertise involved in knot tying, and to decrease the need for revision surgery due to suture knot failure, a wide variety of approaches have been implemented to aid surgeons and physicians in preparing secure sutures.
Examples of general approaches to preparing secure sutures include, for example, throwing multiple hitches when tying a knot; applying glue or adhesive to a knot; twisting, fusing, melting or welding together suture ends; use of clips, anchors, barbs, or other foreign body elements to secure the sutures; and the like. In addition, devices to aid in forming a secure suture are known in the art. Representative examples include U.S. Pat. Nos. 6,866,672, 6,077,277 and 6,432,115 to Mollenauer, et al., which disclose a device for welding suture segments in lieu of tying knots in sutures applied during endoscopic surgery. The disclosed devices provide for snaring loose suture ends and drawing the suture ends into a space between heating surfaces, and provide for closing the heating surfaces to weld the suture ends together.
U.S. Pat. Nos. 5,565,122 and 5,452,513 to Zinnbauer disclose a suture cutter and method of use which is adapted to clamp, sever and cauterize a thermoplastic suture. Closing of a trigger first closes a pivotal jaw against a stationary jaw to hold the suture, and then completes a circuit to sever and cauterize the suture with radiant heat.
U.S. Pat. No. 4,662,068 to Polonsky disclose a suture fusing apparatus that has a forceps type instrument with jaws including a cutting edge and a fusing surface. The jaws are heated and closed on a suture, fusing the suture material together.
U.S. Pat. No. 5,403,331 to Chesterfield, et al. discloses a surgical device for use in a ligating procedure in which a looped suture is slidably secured by a securement member such as shrinkable tubing.
U.S. Pat. No. 5,472,654 to Crawford discloses a manually operable device used to cut a synthetic material and to singe the end of the material to prevent unraveling. This is accomplished by having a crimping assembly, cutting assembly, and burning assembly for each step.
U.S. Pat. No. 6,488,690 to Morris, et al. discloses a hand-held instrument that coagulates suture knots for enhanced security by applying heat to thermoplastic materials.
Although there are a number of approaches for securing sutures, ranging from tying simple knots to sophisticated techniques such as cauterizing and soldering suture ends, what is needed in the art is a device that secures a suture in place during any procedure without the necessity of cumbersome knot tying, and can be used by any surgeon without expert knot-tying skill. The present invention is believed to be an answer to that need.